DEVELOPMENT AND EVALUATION OF SELF NANO EMULSIFYING DRUG DELIVERY SYSTEM FOR TELMISARTANAbstract
Self nano-emulsifying system drug delivery system (SNEDDS) is promising for drugs of BCS class II. The objective of present study to develop self nano-emulsifying drug delivery system for Lipophillic drug Telmisartan (antihypertensive drug), labrafil 1944, Kolliphor ELP: Span 80 (1:1) and PEG 400: Ethanol (1:1) was chosen as oil, Surfactant and Co-surfactant as they show higher solubility for Telmisartan. Screening of Surfactant, Co-surfactant done by percent transmittance and were also observed for turbidity or phase separation visually. Pseudo ternary phase diagram were constructed to identify the self emulsifying regions and also to establish the optimum concentration of oil, surfactant and co-surfactant. Box bhenken desine applied for optimization of formulation. Prepared formulation further Characterization done. Percent Drug Content found 99.71, thermodynamic stability studies show homogenous and no phase separation, Emulsifying Study performed transparent appearance after 24 hr, for robustness Dilutability in water and 0.1N HCl give Percentage Transmittance 99.5 and 100, conducting in vitro dissolution test compared with marketed preparation in stimulated gastric (S.G.F) pH 1.2 showed Percent Drug Release 93.98 with in 30 min, compared by pure drug which was 14.26. Particle size found 164.9 nm which is under nano size range, performing Poly Dispersity Index (PDI) 0.228, Zeta Potential found to be -26.0 mV, by using particle size analyzer.TEM study shows uniform spherical nano emulsion droplets. From the present study it is clear that SNEDDS can be formulated to improve the dissolution and oral bioavailability of poorly water soluble drug Telmisartan.